Amputation, Gait Analysis, Lower Extremity Amputation, Questionnaires
Conditions
Brief summary
This is an observational, prospective multicentric study designed to develop medical knowledge. The aim of the study is to validate the IPAQ-SF questionnaire in a population of lower limb amputee patients. The questionnaire is administered twice to each patient, once during the consultation and again when they return home. Patients also undergo a 6-minute walk test.
Detailed description
This is an observational, prospective multicentric study designed to develop medical knowledge. The IPAQ is an internationally validated questionnaire for measuring physical activity in healthy subjects. The IPAQ-SF (short format of the IPAQ) assesses overall physical activity and sedentary time during the last seven days. The IPAQ-SF has been used in a population of lower limb amputees on several occasions, but no study of its psychometric qualities in application to this population has been performed to date. The main objective of the study is therefore to gather a set of arguments allowing the IPAQ-SF to be used in the follow-up consultation of patients with lower limb amputations who are fitted with a device. This would help health professionals to assess the physical activity of this population and to develop physical activity promotion interventions adapted to their needs. This study is part of the standard management of patients with lower limb amputations and devices. In addition to the clinical data and the result of the 6-minute test from the classical management, the IPAQ-SF questionnaire will be completed twice by the patients included in this study: * Once during the consultation, * Once at home. For the only center equipped (center 01) with inertial sensors, the gait parameters during the 6-minute test will be collected in order to extract fatigue indices. Upon completion of the IPAQ-SF questionnaire a second time, the patient's participation in the study ends.
Interventions
OTHERAdministration of the IPAQ-SF questionnaire
Administration of the IPAQ-SF questionnaire at the patient's consultation and upon return home
Sponsors
FondationbHopale
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to 69 Years
Inclusion criteria
* Patients who have undergone a major lower limb amputation: transtibial, transfemoral, hip or knee disarticulation or trans-iliolumbar * Fitting more than 1 year old * Age 15-69 years (IPAQ-SF not validated outside these ages) * All causes of amputation (vascular, traumatic, tumor, infectious...) * Patient having given their informed consent * Patient affiliated to a social security system
Exclusion criteria
* Subjects with bilateral amputations * Inability to fully and adequately understand the questionnaire (i.e., cognitive impairment, patient does not speak French) * Contraindication to the 6-minute walk test (chest pain, palpitations, mental confusion or lack of coordination and balance, dizziness or malaise, intolerable dyspnea, leg cramps or extreme leg muscle fatigue, any other clinically justified reason). * Patients under legal protection (under guardianship, under curatorship, safeguard of justice) * Pregnant or breast-feeding woman
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of the METs/week questionnaire results with the results of the 6-minute walk test | Data collection during the routine consultation on the day of inclusion | The results of the IPAQ-SF questionnaire will be expressed in METs/week (Metabolic Equivalent of Task). The distance covered by the patient at the end of the 6-minute test will be collected in meters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relationships between the level of amputation and the IPAQ-SF score. | Data collection during the routine consultation on the day of inclusion | 5 levels of amputation : * Hip disarticulation * Transfemoral amputation * Knee disarticulation * Transtibial amputation * Trans-iliolumbar amputation |
| Relationships between the patient's weight and the IPAQ-SF score. | Data collection during the routine consultation on the day of inclusion | Patient's weight in kilogram |
| Relationships between type of prosthesis and the IPAQ-SF score. | Data collection during the routine consultation on the day of inclusion | — |
| Relationships between the age of amputation and the IPAQ-SF score. | Data collection during the routine consultation on the day of inclusion | Age of amputation in years |
| Relationships between the patients ability to perform his or her expected daily functions after rehabilitation (MFCL classification, out of 5 points) and the IPAQ-SF score. | Data collection during the routine consultation on the day of inclusion | The MFCL consists of five ordered categories or 'K-levels' that define increasing functional mobility. |
| Relationship between the physical activity level of patients with lower-limb amputations and the patient's average step length measured by inertial units during the 6-minute test. | Data collection during the 6-minute routine consultation test on the day of inclusion | The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters. Patient's average step length in centimeters during the 6-minute test. |
| Relationship between the physical activity level of patients with lower-limb amputations and the average width of the patient's step measured by inertial units during the 6-minute test. | Data collection during the 6-minute routine consultation test on the day of inclusion | The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters. Patient's average step width in centimeters during the 6-minute test. |
| Relationship between the physical activity level of patients with lower-limb amputations and the patient's walking cadence measured by inertial units during the 6-minute test. | Data collection during the 6-minute routine consultation test on the day of inclusion | The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters. Number of steps per minute during the 6-minute test. |
| Relationships between the physical activity level of lower limb amputee patients and the patient's walking speed measured by inertial units during the 6-minute test. | Data collection during the 6-minute routine consultation test on the day of inclusion | The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters. Patient's walking speed in meters per second during the 6-minute test. |
Countries
France
Contacts
Primary ContactMarine Deseur
Backup ContactElias Ghehioueche
Outcome results
None listed